LUMRYZ meets all primary, key secondary endpoints in Phase 3 idiopathic hypersomnia study

Alkermes plc.

Primary endpoint ESS showed statistically significant improvement vs placebo (p<0.0001).
Key secondary endpoints PGI-C and IHSS also met with p<0.0001.
Safety profile consistent with known LUMRYZ safety; common AEs included nausea, headache.
Alkermes plans to file sNDA with FDA by end of 2026 for IH indication.
Settlement agreement restricts marketing of LUMRYZ for IH until March 1, 2028.

item 7.01item 8.01item 9.01

Source: SEC EDGAR

accession 0001193125-26-218150

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